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NCT00899626 | RECRUITING | Colorectal Cancer

Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples from Colorectal Cancer Patients
Sponsor:

Vanderbilt University Medical Center

Information provided by (Responsible Party):

Kristen K Ciombor

Brief Summary:

RATIONALE: Studying samples of tissue, blood, urine, stool, and other biological fluids from patients with cancer and from healthy volunteers undergoing colonoscopy or endoscopy may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This research study is looking at gastrointestinal biomarkers in tissue and biological fluid samples from patients and participants undergoing colonoscopy, endoscopy, or surgery.

Condition or disease

Colorectal Cancer

Esophageal Cancer

Gastric Cancer

Pancreatic Cancer

Precancerous Condition

Detailed Description:

OBJECTIVES: * Identify new potential biomarkers of increased gastrointestinal cancer risk using tissue and biofluid samples from patients and volunteers undergoing colonoscopy, endoscopy, or surgery. * Develop new screening strategies based on substances found in tissue and biofluid samples. OUTLINE: This is a multicenter study. Patients and healthy volunteers undergo colonoscopy, endoscopy, or surgery. Patients and healthy volunteers also undergo tissue (e.g., tumor or normal mucosa) and biofluid (e.g., blood, urine, cyst fluids or tumor cells, bile and pancreatic juices, and/or stool) sample collection. Samples are analyzed for tumor markers by proteomic methods and protein analysis. If candidate biomarkers are identified, samples are stored for future studies involving these biomarkers. Information, including demographics, personal and family history of cancer, and prior and current colonoscopy, endoscopy, or surgery results, is collected from the medical record and stored in the project database. Patients are followed once a year for up to 5 years to determine if biomarkers have a prognostic significance.

Study Type : OBSERVATIONAL
Estimated Enrollment : 5000 participants
Official Title : Novel Colon Cancer Markers in Gastrointestinal Tissue and Biofluids
Actual Study Start Date : 2002-06
Estimated Primary Completion Date : 2045-10
Estimated Study Completion Date : 2045-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
DISEASE CHARACTERISTICS
  • * Undergoing colonoscopy or endoscopy for diagnostic or screening purposes at the Vanderbilt University Medical Center or at the Veterans Affairs Medical Center AND
  • * Meets 1 of the following criteria
    • * Diagnosis of gastrointestinal (GI) cancer, polyps, or inflammatory bowel disease
    • * History of previously treated GI cancer, polyps, or inflammatory bowel disease
    • PATIENT CHARACTERISTICS
      • * Capable of giving informed consent
      • * Not mentally or medically impaired
      • * No bleeding disorder
      • PRIOR CONCURRENT THERAPY
        • * See Disease Characteristics
Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples from Colorectal Cancer Patients

Location Details

NCT00899626

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Tennessee

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, United States, 37212

RECRUITING

United States, Tennessee

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States, 37232-6838